A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Lebrikizumab; Drug: Standard of Care; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 348
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125 ABE
    • Fundacion Cidea
  • Buenos Aires, Argentina, B6500BWQ
    • Centro Médico Vitae
  • Buenos Aires, Argentina, C1122AAK
    • Fundacion Faicep
  • Ciudad Autónoma de Buenos Aires, Argentina, C1425BEN
    • InAER
  • Mendoza, Argentina, 5500
    • Instituto Respirar
  • Mendoza, Mendoza City, Argentina, M5500CCG
    • INSARES
  • Rosario, Argentina, 2000
    • Centro Respiratorio Infantil
  • San Miguel de Tucuman, Argentina, 4000
    • Investigaciones en Patologias Respiratorias
  • San Miguel de Tucumán, Argentina, T4000CHE
    • Centro Integral de Medicina Respiratoria (CIMER)
  • Santa Fe, Argentina, 3000
    • Instituto Del Buen Aire
  • Santa Fé, Argentina
    • Sanatorio Británico de Rosario
  • Vicente López, Argentina, B1602DQD
    • CEMER Centro Medico de Enfermedades Respiratorias
• Brazil
  • BA
    • Salvador, BA, Brazil, 41940-455
      • Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital Sao Lucas - PUCRS
    • Porto Alegre, RS, Brazil, 90020-090
      • Santa Casa de Misericordia de Porto Alegre
  • SP
    • Santo Andre, SP, Brazil, 09060-650
      • Faculdade de Medicina do ABC - FMABC
    • Santo Andre, SP, Brazil, 09080-000
      • Pesquisare Saúde Sociedade Simples
    • Sao Paulo, SP, Brazil, 01323-020
      • Hospital Alemao Oswaldo Cruz; Pesquisa Clinica
    • Sao Paulo, SP, Brazil, 05437-010
      • Instituto de Pesquisa Clínica e Medicina Avançada Ltda
    • Sorocaba, SP, Brazil, 18040-425
      • CMPC/Clinica de Alergia Martti Antila
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Dr. Tharwat A. Fera Inc.
  • Ontario
    • London, Ontario, Canada, N6A 5B8
      • Brian Lyttle's Private Practice
  • Quebec
    • Quebec City, Quebec, Canada, G1V 4M6
      • Centre de Recherche Appliqué en Allergie de Québec
• Colombia
  • Bogota, Colombia
    • Hospital Santa Clara
  • Medellin-Antioquia, Colombia
    • Hospital Pablo Tobon Uribe
• Czechia
  • Jihlava, Czechia, 586 01
    • Hofstetr Alois MUDr. s.r.o.
  • Teplice, Czechia, 415 01
    • Alergologie Teplice, s.r.o.
• France
  • Bordeaux, France, 33076
    • Groupe Hospitalier Pellegrin; Pharmacie
  • Paris, France, 75015
    • Groupe Hospitalier Necker Enfants Malades
  • Paris, France, 75571
    • Hôpital Armand Trousseau
  • Rouen, France, 76031
    • Hopital Charles Nicolle; cic
• Germany
  • Frankfurt, Germany, 60528
    • Universitaetsklinikum Frankfurt
  • Hamm, Germany, 59063
    • Evangelisches Krankenhaus Hamm
  • München, Germany, 80539
    • Praxis Dr. med. Jan Feimer
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Budapest, Hungary, 1089
    • Heim Pál Gyermekkórház
  • Debrecen, Hungary, 4031
    • Kenezy Korhaz Rendelointezet
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Szigetvár, Hungary, 7900
    • Papp és Társa Bt.
  • Torokbalint, Hungary, 2045
    • Tudogyogyintezet Torokbalint
• Israel
  • Ashkelon, Israel, 78278
    • Barzilai Medical Center
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
  • Petach-Tikva, Israel, 49100
    • Schneider Children's Medical Center
  • Tel Hashomer, Israel, 52661
    • Chaim Sheba Medical Center
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00165
      • Ospedale Pediatrico Bambino Gesu
    • Roma, Lazio, Italy, 00161
      • Azienda Policlinico Umberto I; Dipartimento Integrato di Pediatria e Neuropsichiatria Infantile
  • Lombardia
    • Pavia, Lombardia, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
• Japan
  • Tsu-shi, Japan, 514-0125
    • National Hospital Organization Mie Hospital
  • Yotsukaido, Japan, 284-0003
    • National Hospital Organization Shimoshizu National Hospital
• Korea, Republic of
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 130-702
    • KyungHee Medical Center
• Mexico
  • Ciudad De México, Mexico, 04530
    • Instituto Nacional de Pediatría
  • DF, Mexico, 03310
    • Grupo Medico Camino
  • Guadalajara, Mexico, 44100
    • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
  • Guadalajara, Mexico, 44130
    • Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
  • Guadalajara, Mexico, 44220
    • Unidad Medica de Occidente
  • Monterrey, Mexico, 64460
    • Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas
  • Monterrey, Mexico, 64718
    • Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
  • Villahermosa, Mexico, 86035
    • Consultorio Especialidad Alergologia Pediatrica
• Peru
  • Lima, Peru, Lima 41
    • Clinica San Borja
  • Lima, Peru, Lima 27
    • Clínica Anglo Americana
  • Lima, Peru, Lima 1
    • Clinica Internacional
  • Lima, Peru, Lima 11
    • Hospital Nacional Luis N Saenz PNP
  • Lima, Peru, LIMA 27
    • Centro de Investigación Ricardo Palma
  • Lima, Peru, Lima 01
    • Hospital Dos de Mayo; Parque Historia De la Medicina Peruana S/n
• Poland
  • Bialystok, Poland, 15-430
    • Prywatna Praktyka Lekarska
  • Krakow, Poland, 31-624
    • Malopolskie Centrum Alergologii
  • Lodz, Poland, 90-153
    • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Lodz, Poland, 93-513
    • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
  • Lublin, Poland, 20-552
    • Centrum Alergologii NZOZ
  • Poznan, Poland, 60-214
    • Centrum Alergologii Teresa Hofman
  • Tarnow, Poland, 33-100
    • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
  • Warszawa, Poland, 02-507
    • Klinika Chorób Wewnetrznych i Alergologii MSW
• Portugal
  • Aveiro, Portugal, 3814-501
    • Hospital Infante D. Pedro; Servico de Imunoalergologia
  • Faro, Portugal, 8005-226
    • Hospital Particular do Algarve - Unidade de Faro
  • Lisboa, Portugal, 1169-045
    • Hospital Dona Estefania; Servico de Imunoalergologia
  • Senhora da Hora - Porto, Portugal, 4460-188
    • Hospital CUF Porto; Servico de Imunoalergologia
• Slovakia
  • Kosice, Slovakia, 040 11
    • Alersa
  • Lucenec, Slovakia, 984 01
    • ALERGOMEA s.r.o.
  • Nitra, Slovakia, 949 01
    • Imunoalergologia Dzurilla s.r.o.
• South Africa
  • Cape Town, South Africa, 7925
    • Uni of Cape Town Lung Inst.
  • Durban, South Africa, 4001
    • Sebastian Peter
  • Durban, South Africa, 3630
    • Westville Hospital
  • Johannesburg, South Africa, 1501
    • WWCT Lakeview Hospital
  • Johannesburg, South Africa, 2113
    • Medicross Sophiatown
  • Port Elizabeth, South Africa, 6014
    • GCT Mercantile; Clinical Research Centre
  • Pretoria, South Africa, 0101
    • Bothe ke Bontle Health Services
  • Soweto, South Africa, 1818
    • Soweto Clinical Trial Centre
  • Tabazimbi, South Africa, 0380
    • Limpopo Clinical Research Initiative; Tamboti Medical Centre
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08017
    • Hospital Quiron Teknon
  • Cadiz, Spain, 11008
    • Clinica Dr. Lobatón
  • Madrid, Spain, 28006
    • Clinica Ojeda de Asma Y Alergia
  • Malaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia
    • Esplugues De Llobregas, Barcelona, Spain, 08950
      • Hospital Sant Joan de Déu
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Hospital de Manises
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 402
    • Chung Shan M. U. H.
  • Tainan, Taiwan, 00704
    • National Cheng Kung Univ Hosp
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital
• Ukraine
  • Chernivtsi, Ukraine, 58023
    • Municipal Medical Institution; Chernivtsi Regional Children's Hospital
  • Dnepropetrovsk, Ukraine, 49000
    • Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
  • Kiev, Ukraine, 04050
    • State Institution of Pediatrics Obstetrics and Gynecology of NAMSU
  • Kryvyi Rih, Ukraine, 50082
    • Municipal Institution "Kryvyi Rih City Clinical Hospital #8" of Dnipropetrovsk Regional Council
  • Kyiv, Ukraine, 03680
    • SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
  • Kyiv, Ukraine, 3115
    • SI Research Centre of Radiation Medicine of AMSU
  • Zaporizhzhya, Ukraine, 69063
    • Municipal Institution Zaporizhzhya Regional Clinical Child Hospital
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital
  • Birmingham, United Kingdom, B4 6NH
    • Birmingham Children's Hospital NHS Foundation Trust
  • Dumfries, United Kingdom, DG1 4AP
    • Dumfries and Galloway Royal Infirmary; Department of Paediatrics
  • Glasgow, United Kingdom, G51 4TF
    • Royal Hospital For Children
  • Leicester, United Kingdom, LE1 7RH
    • University of Leicester
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital; Respiratory Department
  • Sheffield, United Kingdom, S102TH
    • Sheffield Childrens Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85716
      • Allergy Associates of Tucson
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles
    • Mission Viejo, California, United States, 92691
      • Southern California Research Center
    • Redwood City, California, United States, 94063
      • Allergy & Asthma Consultants
    • Sacramento, California, United States, 95823
      • Dignity Health Medical Foundation
    • Stockton, California, United States, 95207
      • Bensch Research Associates
    • Walnut Creek, California, United States, 94598
      • Allergy & Asthma Medical Group; Clinical Research Division
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Colorado Children's Hospital; The Breathing Institute
    • Centennial, Colorado, United States, 80112
      • IMMUNOe International Research Centers
    • Colorado Springs, Colorado, United States, 80907
      • Asthma & Allergy; Associates, P.C.
    • Denver, Colorado, United States, 80206
      • National Jewish Medical and Research Center
  • Florida
    • Miami, Florida, United States, 33165
      • Abel and Buchheim
    • Orlando, Florida, United States, 32806
      • Compass Research East, LLC
    • Sarasota, Florida, United States, 34239
      • Sarasota Clinical Research
    • Tampa, Florida, United States, 33613
      • University of South Florida
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Brookstone Clinical Res Ctr
    • Marietta, Georgia, United States
      • Georgia Pain Clinic
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Shiloh, Illinois, United States, 62269
      • The Clinical Research Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children; Pediatric Nephrology
  • Kentucky
    • Florence, Kentucky, United States, 41042
      • Abraham Research PLLC
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Breathe America Shreveport Inc
  • Maryland
    • Baltimore, Maryland, United States, 21236
      • Asthma, Allergy & Sinus Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0718
      • Univ of Michigan Medical Ctr
  • Missouri
    • Saint Louis, Missouri, United States, 63104-1095
      • Cardinal Glennon Child's Hosp; Endrocrinology
  • New Jersey
    • New Jersey, New Jersey, United States, 08904
      • Parikh Institute for Research LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico; School of Med
  • New York
    • New York, New York, United States
      • Parikh Institute for Research LLC
    • The Bronx, New York, United States, 10459
      • Urban Health Plan, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Children's Hospital
  • Oregon
    • Bend, Oregon, United States, 97701
      • Bend Memorial Clinic
    • Lake Oswego, Oregon, United States, 97035
      • Allergy, Asthma, & Dermatology Research Center, Llc
    • Medford, Oregon, United States, 97504
      • Clinical Research Inst. of Southern Oregon, PC
  • Texas
    • Boerne, Texas, United States, 78006
      • TTS Research
    • El Paso, Texas, United States, 79925
      • Allergy & Asthma Research Center of El Paso
    • San Antonio, Texas, United States, 78251
      • Allergy & Asthma Res Ctr PA
    • San Antonio, Texas, United States, 78251
      • South Texas Allergy and Asthma Medical Professionals
  • Utah
    • North Logan, Utah, United States, 84341
      • Bridgerland Clinical Research
  • Virginia
    • Fairfax, Virginia, United States, 22030
      • O & O Alpan, LLC
  • Washington
    • Bellingham, Washington, United States, 98225
      • Bellingham Asthma, Allergy & Immunology
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Asthma diagnosis for greater than or equal to (>/=) 12 months prior to Visit 1
• Bronchodilator response during screening
• Pre-bronchodilator FEV1 of 40 percent (%) - 90% predicted at both Visits 2 and 3
• On high dose ICS therapy for >/= 6 months prior to Visit 1
• On an eligible second controller medication for 6 months prior to Visit 1
• Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization
• Demonstrated adherence with controller medication during the screening period

Exclusion Criteria:

• History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
• Maintenance oral corticosteroid therapy within 3 months prior to Visit 1
• Treatment with systemic (oral, intravenous [IV], or intramuscular [IM]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period
• Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study
• Infection that meets the following criteria: Any infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; any active infection that required treatment with oral antibiotics within 2 weeks prior to Visit 1 or during screening; upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
• History of active tuberculosis requiring treatment
• Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
• Evidence of acute or chronic hepatitis or known liver cirrhosis
• History of cystic fibrosis, bronchiectasis, and/or other clinically significant lung disease other than asthma
• Diagnosis or history of malignancy or current evaluation for potential malignancy
• Current smoker or former smoker with a history of greater than (>) 10 pack-years
• History of alcohol or drug abuse
• Past and/or current use of any anti- interleukin (IL) -13 or anti-IL-4/IL-13 therapy, including lebrikizumab
• Use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives (whichever is longer) prior to Visit 1
• Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening
• History of bronchial thermoplasty

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lebrikizumab High; Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 micrograms [mcg] of fluticasone propionate dry powder inhaler [DPI] or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (high dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period.	Drug: Lebrikizumab; Lebrikizumab will be administered as SC injection at high or low dose Q4W.; Drug: Standard of Care; Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists [LABAs], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.
EXPERIMENTAL: Lebrikizumab Low; Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (low dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period.	Drug: Lebrikizumab; Lebrikizumab will be administered as SC injection at high or low dose Q4W.; Drug: Standard of Care; Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists [LABAs], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.
PLACEBO_COMPARATOR: Placebo; Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab matching placebo Q4W for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at high or low dose will be administered from Weeks 52 to 76 or 104 to participants who are willing to take part in optional active-treatment extension period.	Drug: Lebrikizumab; Lebrikizumab will be administered as SC injection at high or low dose Q4W.; Drug: Standard of Care; Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists [LABAs], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.; Drug: Placebo; Lebrikizumab matching placebo will be administered as SC injection Q4W.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period	Baseline up to Week 52
Percentage of Participants With Adverse Events (AEs) or Serious AEs	Baseline up to Week 124
Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab	Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 76, 104, 112, and 124 or at early termination [up to 108 weeks])

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at Week 52	Baseline , Week 52
Time to First Asthma Exacerbation	Baseline up to 52 weeks
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 52	Baseline , Week 52
Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and Older (AQLQ + 12) at Week 52	Baseline, Week 52
Change From Baseline in Asthma Rescue Medication Use at Week 52	Baseline, Week 52
Rate of Urgent Asthma-Related Health Care Utilization	Baseline up to 52 weeks
Injection Acceptability Questionnaire (IAQ) Score	Baseline up to Week 104

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Szefler SJ, Roberts G, Rubin AS, Zielen S, Kuna P, Alpan O, Anzures-Cabrera J, Chen Q, Holweg CTJ, Kaminski J, Putnam WS, Matthews JG, Kamath N. Efficacy, safety, and tolerability of lebrikizumab in adolescent patients with uncontrolled asthma (ACOUSTICS). Clin Transl Allergy. 2022 Jul 14;12(7):e12176. doi: 10.1002/clt2.12176. eCollection 2022 Jul.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2013
• Primary Completion (ACTUAL): December 28, 2016
• Study Completion (ACTUAL): December 28, 2016

Study Registration Dates

• First Submitted: June 7, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (ESTIMATE): June 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: WB28183; 2012-000180-25 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes